Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma

This study has been completed.
Sponsor:
Information provided by:
Vical
ClinicalTrials.gov Identifier:
NCT00003647
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: July 2008
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV melanoma.


Condition Intervention Phase
Stage IV Melanoma
Stage III Melanoma
Recurrent Melanoma
Drug: allovectin-7
Drug: allovectin-7/dacarbazine
Drug: dacarbazine
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Vical:

Study Start Date: July 1998
Study Completion Date: September 2002
Detailed Description:

OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression by at least 2 months with no decrease in the rate of objective clinical response OR an improvement by at least 15% in the rate of objective clinical response with no decrease in the median time to disease progression in patients with stage III or IV melanoma receiving dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone.

II. Determine the benefits, risks, and side effects of these regimens in this patient population.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sex, age, and spread of disease (cutaneous or nodal vs visceral disease). Patients are randomized to one of two treatment arms.

Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10.

Patients with stable or responding disease may receive additional courses every 28 days.

Patients are followed every 4 months.

PROJECTED ACCRUAL:

A total of 280 patients (140 in each arm) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Histologically confirmed stage III or IV melanoma 1 or more metastatic tumors for which surgery is not deemed to be a curative option
  • Dacarbazine is indicated as first line chemotherapy
  • At least 1 measurable tumor at least 1 cm2 but no greater than 100 cm2
  • No history of brain metastases

--Prior/Concurrent Therapy--

  • Biologic therapy: At least 4 weeks since prior biologic therapy
  • Chemotherapy: See Disease Characteristics; No prior chemotherapy
  • Endocrine therapy: No concurrent immunosuppressive drugs
  • Radiotherapy: At least 4 weeks since prior radiotherapy
  • Surgery: At least 2 weeks since prior major surgery
  • Other: No other concurrent anticancer drug therapy or experimental therapy

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: Karnofsky 80-100%
  • Life expectancy: At least 24 weeks
  • Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL
  • Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT less than 3 times upper limit of normal (ULN); PT/PTT normal; Albumin normal; LDH no greater than 2 times ULN
  • Renal: Creatinine no greater than 2.0 mg/dL
  • Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease
  • Other: HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus; No other prior malignancy within the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003647

  Show 44 Study Locations
Sponsors and Collaborators
Vical
Investigators
Study Chair: Cherie Smith Vical
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003647     History of Changes
Obsolete Identifiers: NCT00416416
Other Study ID Numbers: CDR0000066736, VCL-1005-301
Study First Received: November 1, 1999
Last Updated: July 23, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Vical:
adult solid tumor
body system/site cancer
cancer
melanoma
recurrent melanoma
skin tumor
solid tumor
stage III melanoma
stage IV melanoma
stage, melanoma

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014